Biotech Validation Manager – Cleaning & Sterilization Lead

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen Inc. in North Carolina seeks a Manufacturing Manager for Cleaning Validation Live, leading validation strategy and master plans at ANC.

You will oversee autoclave performance qualification, cleaning validation, and validation maintenance, ensuring compliance with regulatory standards. The role requires building and directing a team, authoring and reviewing validation documents, and coordinating with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to meet Amgen

Qualifications

• Doctorate degree OR Master’s degree and 3 years of Validation or Engineering experience OR Bachelor’s degree and 5 years of Validation or Engineering experience OR Associate’s degree and 10 years of Validation or Engineering experience OR High school diploma/GED and 12 years of Validation or Engineering experience
• Experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Responsibilities

• Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilization program.
• Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC
• Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment
• Supply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports)
• Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met
• Furnish technical assistance and represent validation for regulatory filings, audits, and inspections
• Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems
• Support site/network validation driven continuous improvement initiatives

Skills

Leadership

Technical writing

Validation

Equipment qualification

Cleaning validation

Regulatory compliance

Education

PhD

MS in Engineering

BS in Engineering

Associates degree

High school diploma

Job description

Amgen Inc. in North Carolina seeks a Manufacturing Manager for Cleaning Validation Live, leading validation strategy and master plans at ANC.

You will oversee autoclave performance qualification, cleaning validation, and validation maintenance, ensuring compliance with regulatory standards. The role requires building and directing a team, authoring and reviewing validation documents, and coordinating with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to meet Amgen